Cleared Traditional

K934981 - DENTAL DRILL (FDA 510(k) Clearance)

Class I Dental device.

K934981 · Eare Consulting Service · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
107d
Days
Class 1
Risk

K934981 is an FDA 510(k) clearance for the DENTAL DRILL. Classified as Instrument, Diamond, Dental (product code DZP), Class I - General Controls.

Submitted by Eare Consulting Service (Eilat, IL). The FDA issued a Cleared decision on February 3, 1994 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4535 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Eare Consulting Service devices

Submission Details

510(k) Number K934981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1993
Decision Date February 03, 1994
Days to Decision 107 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 127d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DZP Instrument, Diamond, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4535
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.